Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety and Efficacy of the Luxe Device to Treat Facial Wrinkles and Rosacea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Syneron Medical
ClinicalTrials.gov Identifier:
NCT01618864
First received: June 11, 2012
Last updated: July 20, 2014
Last verified: July 2014
  Purpose

This study is designed to evaluate the efficacy and safety of the Luxe™ device for use in wrinkle and rosacea treatment.

Up to 60 subjects will treat their periorbital and cheek areas daily for 4 weeks and then twice a week for an additional 4 weeks. Evaluations of improvement will be conducted at the clinic after enrollment and during the treatment at 1, 2, 4, and 8 weeks after initiation.


Condition Intervention
Rosacea
Wrinkles
Device: Luxe

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy Evaluation of the Luxe™ Device for the Treatment of Facial Wrinkles and Rosacea

Resource links provided by NLM:


Further study details as provided by Syneron Medical:

Primary Outcome Measures:
  • Improvement in Investigator Assessment of Overall Global Aesthetic Improvement Scale (GAI) [ Time Frame: 4, 8 weeks ] [ Designated as safety issue: No ]
    Data reported as percentage of participants showing improvement in overall score as assessed by investigator. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement)provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage.


Secondary Outcome Measures:
  • Subject Improvement Using the Global Aesthetic Improvement (GAI) Scale [ Time Frame: 4, 8 weeks ] [ Designated as safety issue: No ]
    Data reported as percentage of participants showing improvement in overall score as assessed by subject. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement) provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage. Analogous to Outcome Measure 1.

  • Reduction in Rosacea by the Study Investigator Using a Validated Scale [ Time Frame: 4, 8 weeks ] [ Designated as safety issue: No ]
    Data reported as percentage of participants showing improvement in rosacea scale: 4 point scale for presence of rosacea features from 0 (absent) to 3 (severe) for: flushing, nontransient erythema, papules and pustules and telangiectasia.


Enrollment: 23
Study Start Date: March 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Luxe Device: Luxe
Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male or female between the ages of 21 and 60.
  2. Non-smoker.
  3. Have no prior experience with the Luxe™ device.
  4. Having wrinkles, rhytides and fine lines in periorbital regions that are classified as wrinkle type 1-3 on the Crow's Feet Grading Scale and/or having rosacea cheeks regions.
  5. Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
  6. Agree to make no changes in their existing skin-care regime, other than use of the study products, during the study period.
  7. Able to understand and provide written Informed Consent.
  8. Women of child-bearing age should pass a negative pregnancy test, and required to be using a reliable method of birth control at least 3 months prior to and throughout study enrollment.

Exclusion Criteria:

  1. Fail to meet any of the inclusion criteria above.
  2. Subject unable or unwilling to provide proper informed consent for participation.
  3. Subject not able to understand the requirements of the study.
  4. Pregnant or nursing women or intending to become pregnant during the course of study.
  5. Reported having one of the following medical conditions that could result in potential harm to themselves or other:

    • Obvious cognitive deficit.
    • Neuromotor control difficulty with either hand.
    • Sensitivity to light.
    • History of light activated medical problems such as light triggered seizure disorders or migraine headaches.
    • Taking drugs which may cause light sensitivity.
  6. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
  7. Having a permanent implant in the treated area, such as metal plates and screws
  8. Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study.
  9. Prior or current skin therapy that may interfere with the evaluation of the study device: Renova, AHAs, Vitamin C, Kinerase, Tretinoin, Topical Retinoids, Topical Steroids, Antibiotics (topical or oral) within 14 days of baseline visit.

    Oral Retinoids within 6 month of baseline visit.

  10. Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study.
  11. Subject currently being treated for a dermatologic condition which may interfere with the safe evaluation of the study device (Eczema, Psoriasis, Severe sun damage, Dermatitis).
  12. Patient on systemic corticosteroid therapy 6 months prior to and throughout the course of the study.
  13. Subject with a history of hypersensitivity or allergy to (LED) light.
  14. Subject with a history of hypersensitivity or allergy to any formulation or device component.
  15. Having received a facial dermabrasion or chemical peel treatment within 3 months of treatment or during the study.
  16. Prior skin treatment with laser in treated area within 3 months of initial treatment or during the course of the study.
  17. Prior use of Botox, collagen, fat injections and /or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 2 month of initial treatment or during the course of the study. Treatment may not be performed, at all, over permanent dermal implants.
  18. Prior ablative resurfacing procedure, brow lift, blepharoplasty or face lift in treated area with laser or other devices within 12 months of initial treatment or during the course of the study.
  19. Any other surgery in treated area within 12 months of initial treatment or during the course of the study.
  20. History of keloid formation or poor wound healing in a previously injured skin area.
  21. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
  22. Open laceration or abrasion of any sort on the area to be treated.
  23. Active Herpes Simplex I at the time of treatment.
  24. Multiple dysplastic nevi in the area to be treated.
  25. Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to the treatment (as per the subject's physician discretion).
  26. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
  27. Having any form of active cancer (especially skin cancer: BCC, SCC, and Melanoma) at the time of enrollment and during the course of the study.
  28. Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the investigator would interfere with the treatment, or healing process.
  29. Subjects who have initiated treatment with hormones including estrogen, progesterone, or oral contraceptives for 12 weeks or less, immediately preceding study entry, who intend to discontinue hormonal therapy during the study.
  30. Participation in a study of another device or drug within 1 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria.
  31. Subjects with history of past or present drug/ alcohol abuse.
  32. Mentally incompetent, prisoner or evidence of active substance.
  33. Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618864

Locations
United States, New York
New York Laser & Skin Care
New York, New York, United States, 10028
Sadick Dermatology
New York, New York, United States, 10075
Sponsors and Collaborators
Syneron Medical
Investigators
Principal Investigator: Neil Sadick, MD Sadick Dermatology
Principal Investigator: Arielle NB Kauvar, MD New York Laser & Skin Care
  More Information

No publications provided

Responsible Party: Syneron Medical
ClinicalTrials.gov Identifier: NCT01618864     History of Changes
Other Study ID Numbers: Luxe01
Study First Received: June 11, 2012
Results First Received: June 10, 2014
Last Updated: July 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014